SOP FOR PROCEDURE FOR CLEANING, OPERATION AND CALIBRATION OF DIGITAL HARDNESS TESTER
SOP FOR PROCEDURE FOR CLEANING, OPERATION, AND CALIBRATION OF DIGITAL HARDNESS TESTER
Author: Pharma Editor
SOP For Calibration procedure for pH meter
SOP For Calibration procedure for pH meter OBJECTIVE To describe the calibration procedure for pH meter. SCOPE This SOP shall be applicable for the calibration procedure for pH meter RESPONSIBILITY Quality Control Executive/Officer. ACCOUNTABILITY Quality Control Manager PROCEDURE Operate the Instrument as per procedure. Insert the pH electrode and temperature sensor in buffer solution pH…
PROCEDURE FOR HANDLING AND CALIBRATION OF VERNIER CALIPER
PROCEDURE FOR HANDLING AND CALIBRATION OF VERNIER CALIPER
HANDLING OF MARKET COMPLAINTS
HANDLING OF MARKET COMPLAINTS To provide the procedure for handling of market complaints and to ensure that all complaints related to drug products are recorded and investigated promptly with the aim of addressing them in a timely manner to satisfy the complainant, adhere to compliance requirements as well as to prevent future occurrences. SCOPE: This…
SOP For Control of Completed Batch Production
SOP For Control of Completed Batch Production OBJECTIVE : To provide a procedure for the proper control of completed Batch Production Records (BPR) after the release of finished drug products for distribution. RESPONSIBILITY : Officer – Quality Assurance. Officer – Documentation. Head of Quality Assurance Department to ensure compliance. PROCEDURE All completed Batch Production Records…
Review of Batch Production Records
Review of Batch Production Records OBJECTIVE : To provide a procedure for the review of the Batch production records (BPR) before releasing drug products, in order to verify compliance with cGMP requirements and all established specifications and written procedures in the manufacturing of the product batch. RESPONSIBILITY : Quality Assurance Officer. Head of Quality Assurance…
SOP For Release of Finished Products
SOP For Release of Finished Products OBJECTIVE : To lay down the procedure for QA release of Finished Product for distribution. RESPONSIBILITY : Quality Assurance Officer. Head of Quality Assurance Department to ensure compliance. PROCEDURE : After receiving Finished Product Release Report (FRR) (Annexure – 1) from Production Department, QA – Officer shall check the…
SOP For Process Area clearance during batch/product changeover
SOP For Process Area clearance during batch/product changeover OBJECTIVE : To provide a procedure for Process area clearance during batch/product changeover. RESPONSIBILITY : Officer Quality Assurance for implementation Head of Quality Assurance Department to ensure compliance. PROCEDURE : Note: Type-A Area clearance : During the batch changeover of the same product. Type-B Area clearance :…
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SOP For Assigning of repacking before date
SOP For Assigning repacking before the date OBJECTIVE : To lay down the procedure for assigning ‘repack before date’. RESPONSIBILITY : Officer Production/Officer Quality Assurance Head – Quality Assurance to ensure compliance. PROCEDURE The ‘repack before date’ shall be assigned from the day packing is initiated. The basis for a period of repacking before shall…
SOP on Cleaning of Sampling Aids
SOP on Cleaning of Sampling Aids OBJECTIVE : To lay down a procedure for cleaning Sampling Aids. RESPONSIBILITY : Officer – Quality Quality Assurance to implement the procedure. Head – Quality Quality Assurance to ensure compliance. PROCEDURE : Preparation of Detergent solution (2% Extran MA 02 Neutral, solution). To about 980 mL of potable water…
SOP on Annual Product Review of Drug Product Quality (APQR)
SOP on Annual Product Review of Drug Product Quality (APQR) OBJECTIVE : To establish a procedure for the preparation, review, and approval of Annual product reviews to assure the consistent and acceptable quality of each product manufactured for distribution and apprise upper management of any changes needed. RESPONSIBILITY : Officer – Quality Assurance to compile…
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SOP on Cleaning Validation in pharmaceutical company
SOP on Cleaning Validation in a pharmaceutical company OBJECTIVE : To establish and explain the procedure to be followed for the cleaning Validation of Standard Cleaning Procedures (SCP)s, in order to Assure that the fitness of the equipment is adequately protected for every product. Demonstrate that no cross-contamination will be observed on shared equipment between…
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Reporting, Investigating and Disposition of Incidents
Reporting, Investigating, and Disposition of Incidents OBJECTIVE: To lay down a procedure for reporting, investigating, and disposing of incidents in the Quality Assurance Department. RESPONSIBILITY : Officer-QA to raise the Incident Report to allot number & due date to the Incident Report. Officer-QA & Head-QA or his designee to investigate and take necessary corrective actions….
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Packaging Area/Line Clearance during batch/product change over
OBJECTIVE : To outline the procedure for the Packaging Area/Line clearance before the start up of any packaging operation, to ensure that the packaging area/line has been thoroughly cleaned and that all coded labeling and packaging materials of the previous batch/product have been completely removed. RESPONSIBILITY : Officer – Production Packaging Officer – Quality Assurance…
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Cleaning of Unit Dose and Large Volume Sampling Thieves
Cleaning of Unit Dose and Large Volume Sampling Thieves OBJECTIVE : To lay down the procedure for cleaning unit dose and large volume sampling thieves. RESPONSIBILITY : Executive -Quality Assurance to implement the procedure. Head – Quality Assurance to ensure compliance. PROCEDURE : Preparation of Detergent solution (2% Extran MA 02 Neutral, solution): To about…
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Responsibilities of Quality Assurance Department
Responsibilities of the Quality Assurance Department OBJECTIVE : To lay down the responsibilities of the Quality Assurance Department. RESPONSIBILITY : All personnel of the Quality Assurance Department. Head of Quality Assurance Department to ensure compliance. PROCEDURE : The Quality Assurance department shall be responsible to formulate systems for the implementation of cGMP and, to ensure…
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Operation and Callibration of Water HPLC
Operation and Calibration of Water HPLC HPLC Privileges on application software waters
Procedure for operation of IR Spectrophotometer (SHIMADZU)
OBJECTIVE To lay down the procedure for operation of Fourier Transform Infrared Spectro-photometer (Shimadzu) SCOPE This SOP shall be applicable for Quality Control in Quality Assurance department. RESPONSIBILITY Quality Control Executive/Officer. ACCOUNTABILITY Quality Control Manager. PROCEDURE FOR CLEANING Check that the power supply to the instrument is switched ‘ OFF ‘ before cleaning. Clean the…
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Collection, Storage and Control of Reserve Samples for Drug Products
Collection, Storage, and Control of Reserve Samples for Drug Products OBJECTIVE : To lay down a procedure for collection, storage, retrieval, and disposition of reserve samples of drug products. RESPONSIBILITY : Quality Assurance Officer for collection, storage, retrieval, and disposal of reserve samples. Head of Quality Assurance Department to ensure compliance. PROCEDURE : Every batch/lot…
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Correction of Documentation Errors
OBJECTIVE : To provide a procedure for correction of any documentation error, occurred during documenting data in operating departments (like Quality Control, Production, Warehouse, Engineering, QA) RESPONSIBILITY : Personnel of concerned department to implement. Heads of concerned departments to ensure compliance. PROCEDURE : All personnel shall avoid making data entry errors. In case an entry…